Recruiting: Novel Dynamic Proteomics Approaches to Investigate the Systems Level Pathology of ME/CFS

About the study

Why is your participation in this research project important?

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is an extremely disabling condition, associated with many different symptoms, including post-exertional malaise. Any form of physical or mental exertion can lead to a worsening of symptoms.

ME/CFS can affect a person’s ability to perform normal tasks, severely impacting on quality of life and independence. It is not well known or understood, even though it is currently estimated that ME/CFS is as common as more well-known conditions such as Rheumatoid Arthritis.

Even though there has been more research into ME/CFS in recent years, we still do not understand the causes. This makes accurate diagnosis very difficult, and the search for an effective treatment even more challenging.

It has been difficult to understand what causes ME/CFS, partly because it is a complex condition affecting a number of different systems, tissues and organs in the body. It often starts suddenly, with someone going from fit and healthy to bedbound in a matter of days. These factors can also make it difficult to identify what is causing the disease.

Proteomics

Because of the complexities surrounding ME/CFS, a new and novel approach is needed in researching the underlying causes. In recent years an analytical technique called proteomics has provided good promise in other conditions. It has helped to identify potentially unknown factors which may be contributing to the onset of disease.

Proteomics works by measuring the levels of several hundred to thousands of proteins present within a blood or tissue sample at the same time. Proteins are the compounds that make up our cells and help to control their function.

By looking at the differences between the levels of many proteins in someone with the disease compared to someone without the disease, we can potentially identify which proteins, and hence which pathways and/or tissues in the body, may be important in the development of the disease.

Standard proteomics techniques do not take into account the fact that the metabolic processes in our body are constantly changing, so that a single measure at one point in time may completely miss key changes important to the disease cause.

The aim of this project therefore, is to use a new type of proteomics technique called dynamic proteomics. Dynamic proteomics measures the levels of proteins in blood and tissue samples at several different time points, to capture important dynamic changes that are occurring in the metabolism of ME/CFS patients.

 This may provide the detailed insight needed to understand which factors in the body control ME/CFS symptoms and disease progression. This would be a very important step in helping to improve quality of life for sufferers of this devastating condition.

What are the exclusion criteria for this study?

For this study we are recruiting:

1. Healthy female volunteers aged between 20 and 50 years, who are of normal weight. If you have been a subject in any other research study in the last three months which involved: taking a drug, being paid an inconvenience allowance or having an invasive procedure (e.g. blood sample >50ml), you would not be eligible to take part.
2. Female volunteers suffering from ME/CFS of the same age as outlined by the 1994 CDC-Fukuda and 2003 Canadian case definitions for ME/CFS.

You would also be unsuitable if you have particular medical conditions (such as neurological conditions) or are taking certain medications. If you are interested in this study, please discuss these further with the research team.

Some immediate questions you may have:

Why have you been chosen?

• In order for this study to be successful we need to recruit 10 females with ME/CFS who are aged 20 to 50 years, and 10 healthy females of a similar age.

Do you have to take part?

• No, participation is entirely voluntary. If you decide to take part, you are still free to withdraw at any time without giving a reason

What does my participation involve?

• You will be asked to attend the Medical School at the Royal Derby Hospital Centre for a number of study visits which are summarised in the Participant Information Sheet.

Precautions

To avoid and minimise potential non-exercise induced PEM, the following adaptations and additions to the above protocol can be included where requested or needed:

• All unnecessary travel will be avoided where possible, however where needed you will be provided with pre-booked taxi transport to bring you to the research facility.
• Initial screening (excluding ECG, BP and blood sampling) will take place at your home or remotely (phone or via video conferencing application) if requested.
• The tracer administration and stitch removal can be performed at your home home where possible to avoid any unnecessary exacerbation of PEM symptoms.
• To minimise PEM for any on-site visits, you will be provided with regular rest breaks in designated rooms which are adapted to the needs of the volunteers condition. These will be discussed with you at screening as we understand that the ME/CFS is a very individual condition, one thing that might be comfortable for one volunteer, may not be for another. Individual measures can be put in place to minimise discomfort as needed.

Contact for Further Information

Thank you for your interest in this study. For further information please contact: Daniel Wilkinson, by email: d.wilkinson@nottingham.ac.uk, or telephone: 01332 724850.

The research team can also be reached at The University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, Royal Derby Hospital, Derby, DE22 3DT.

• Download the Participant Information Sheet which has the full details about the study. It is a very thorough document and we recommend that you take time to read it carefully before making any decision.